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Study on the Effectiveness and Safety of Zasocitinib (TAK-279) for Patients with Active Psoriatic Arthritis with Previous Biologic Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called zasocitinib, also known by its code name TAK-279, in people with a condition called psoriatic arthritis. Psoriatic arthritis is a type of arthritis that affects some people who have psoriasis, a condition that features red patches of skin topped with silvery scales. The study aims to evaluate how effective and safe zasocitinib is for treating this condition. Participants in the study will receive either zasocitinib or a placebo, which is a substance with no active medication, to compare the outcomes.

The study will be conducted over a period of time, during which participants will take the medication in the form of a film-coated tablet. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will also consider the participants' previous use of biologic treatments, which are advanced medications used to treat psoriatic arthritis.

Throughout the study, participants will be monitored to assess the medication's impact on their condition. This includes looking at improvements in joint tenderness and swelling, as well as skin symptoms associated with psoriasis. The study will also evaluate changes in participants' overall health and quality of life. The goal is to determine if zasocitinib can provide significant relief from the symptoms of psoriatic arthritis compared to the placebo. The study is expected to continue until 2028, with recruitment starting in 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide your informed consent. This means you agree to participate and understand the study procedures and requirements.

    You will need to confirm that you meet the eligibility criteria, such as being 18 years or older and having active psoriatic arthritis for at least 3 months.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your condition. This includes checking for at least 3 tender and 3 swollen joints and any active skin lesions.

    Your current medications will be reviewed to ensure they are stable and meet the study's requirements.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either zasocitinib or a placebo. Both are taken as oral film-coated tablets.

    The dosage and frequency will be determined by the study protocol, and you will be informed of the schedule.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular visits will be scheduled to monitor your health and the effects of the medication.

    You will be assessed for improvements in your condition, such as achieving a 20% improvement in symptoms by week 16.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

    You will be asked to provide feedback on your experience and any changes in your condition.

Who can join the trial?

11 criteria

  • The person must be willing and able to understand and follow the study procedures and requirements.
  • The person must provide written consent to participate in the study.
  • The person must be at least 18 years old.
  • The person must have had signs and symptoms of **Psoriatic Arthritis (PsA)** for at least 3 months.
  • The person must meet the **Classification Criteria for Psoriatic Arthritis (CASPAR criteria)**, which are specific guidelines used to diagnose PsA.
  • The person must have active arthritis, shown by at least 3 tender and 3 swollen joints at the screening and baseline visits.
  • The person must have at least one active **plaque psoriasis (PsO)** lesion that is 2 cm or larger, or any nail changes characteristic of PsO.
  • The person must have had an inadequate response to certain medications for PsA, such as **nonsteroidal anti-inflammatory drugs (NSAIDs)**, **conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)**, or **biologic DMARDs**. This means the medications did not work well enough or caused side effects.
  • If the person is taking csDMARDs, they must be on no more than 2 of these medications for at least 12 weeks, with stable doses for at least 4 weeks before the study starts. Specific dose limits apply to medications like **methotrexate (MTX)**, **sulfasalazine (SSZ)**, **leflunomide (LEF)**, and **hydroxychloroquine (HCQ)**. The combination of MTX and LEF is not allowed.
  • If the person is taking other treatments for PsA, such as oral corticosteroids, NSAIDs, or certain pain relievers, the doses must be stable for at least 1 week before the study starts.
  • The person must meet specific birth control requirements if they have the potential to become pregnant. This includes being surgically sterile, confirmed postmenopausal, or agreeing to use a highly effective method of contraception during the study and for 10 days after the last dose. If using oral hormonal contraception, a second method should be used as well.

Who cannot join the trial?

9 criteria

  • Having any other active autoimmune disease, which means a condition where the immune system attacks the body.
  • Having a history of severe allergic reactions to medications.
  • Currently having an infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Having a history of cancer within the last 5 years, except for certain types of skin cancer.
  • Being pregnant or breastfeeding.
  • Having a history of drug or alcohol abuse within the past year.
  • Having received any live vaccines within 4 weeks before starting the study.
  • Having any significant medical condition that the study doctors believe would make it unsafe to participate.
  • Currently participating in another clinical trial or having participated in one within the last 30 days.
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Investigated drugs

Zasocitinib is a medication being studied for its potential to help people with psoriatic arthritis, a condition that causes joint pain and swelling. This medication works by targeting specific pathways in the immune system that are involved in causing inflammation. By doing so, it aims to reduce the symptoms of psoriatic arthritis, such as pain and swelling, and improve the overall quality of life for those affected by this condition. The study is looking at how effective and safe this medication is for people who have not responded well to other treatments.

What is already known about the treatment

Zasocitinib – Zasocitinib is administered orally in the form of a tablet. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating active psoriatic arthritis, a condition characterized by joint inflammation and skin lesions. The medication works by targeting specific pathways in the immune system to reduce inflammation and alleviate symptoms. Zasocitinib is classified as a Janus kinase (JAK) inhibitor, which helps to modulate the immune response in the body.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can vary in severity. The disease often progresses with periods of flare-ups and remissions. Over time, it can lead to joint damage and reduced mobility if not managed properly. Psoriatic arthritis can also affect other parts of the body, including the skin, nails, and eyes. The progression of the disease can be influenced by various factors, including genetic predisposition and environmental triggers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513112-99-00Protocol codeTAK-279-PsA-3002Estimated enrolment600 patientsSponsorTakeda Development Center Americas Inc.

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